WO2015105873A1 - Traitement d'affections buccales au moyen d'un courant électrique - Google Patents

Traitement d'affections buccales au moyen d'un courant électrique Download PDF

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Publication number
WO2015105873A1
WO2015105873A1 PCT/US2015/010477 US2015010477W WO2015105873A1 WO 2015105873 A1 WO2015105873 A1 WO 2015105873A1 US 2015010477 W US2015010477 W US 2015010477W WO 2015105873 A1 WO2015105873 A1 WO 2015105873A1
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WO
WIPO (PCT)
Prior art keywords
oral
microamps
cavity
electrically conductive
conductive surface
Prior art date
Application number
PCT/US2015/010477
Other languages
English (en)
Inventor
Paul L. RUFLIN
Michael J. Keller
Michael V. KAMINSKI
Scott Mizer
Robert Armstrong
Original Assignee
Animal Oralectrics Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Animal Oralectrics Llc filed Critical Animal Oralectrics Llc
Priority to CA2936087A priority Critical patent/CA2936087C/fr
Priority to AU2015204825A priority patent/AU2015204825A1/en
Priority to EP15735071.1A priority patent/EP3092031A4/fr
Publication of WO2015105873A1 publication Critical patent/WO2015105873A1/fr
Priority to AU2019250172A priority patent/AU2019250172B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0548—Oral electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D5/00—Instruments for treating animals' teeth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes

Definitions

  • This invention relates to a method of concurrently promoting general oral hygiene in non-human animals, treating periodontal diseases such as gingivitis and periodontitis, killing oral microbes including cavity-causing bacteria, reducing oral biofilms, increasing blood flow in oral tissues, increasing salivation, promoting gingival tissue regeneration, fostering osteogenesis in the boney structures of the teeth, mouth and related areas, treating systemic diseases associated with oral bacteria, and treating other periodontal and oral maladies through the noninvasive application of weak direct current electricity to the surfaces in the oral cavity, and it also relates to an apparatus suitable for providing direct current electricity for these therapeutic, prophylactic, and regenerative effects.
  • Periodontal disease has been identified as a risk factor for various systemic diseases by dentists, physicians, and veterinarians. Included in these diseases are cardiovascular disease, adverse pregnancy outcomes, and diabetes with newfound evidence supporting its association with pancreatic diseases and arthritis. While many of the studies establish correlation between the presence of periodontal disease and these systemic conditions, causation, with most of these conditions, is still a subject of ongoing research. A few of the biological mechanisms which have been proposed as to how oral bacteria stemming from periodontal disease can cause systemic disease are as followed:
  • Oral microbes and their byproducts can gain systemic access via the circulatory system through traveling through compromised tissue and inflamed periodontium in the oral cavity. In gaining systemic access, oral microbes have the potential to directly influence subclinical mediators of various systemic diseases.
  • Inflammation People with periodontal disease have elevated levels of systemic inflammatory markers due to the burden of increased levels of oral bacteria. Treatment for periodontal disease has been reported to decrease systemic inflammation levels.
  • Cross-reactivity The progression of systemic diseases can be accelerated by the immune response to bacterial heat-shock proteins creating antibodies that cross-react with innate heat shock proteins expressed on cells of the damaged tissues.
  • the present invention relates to an apparatus for aiding overall oral health of a non-human animal, and more particularly to treating periodontal diseases such as gingivitis and periodontitis, killing oral microbes including cavity-causing bacteria, reducing oral biofilms, increasing blood flow in oral tissues, increasing salivation, promoting gingival tissue regeneration, fostering osteogenesis in the boney structures of the teeth, mouth and related areas, treating systemic diseases associated with oral bacteria, and treating other periodontal and oral maladies through the non-invasive application of weak direct current electricity to the surfaces in the oral cavity.
  • periodontal diseases such as gingivitis and periodontitis
  • killing oral microbes including cavity-causing bacteria such as gingivitis and periodontitis
  • reducing oral biofilms including cavity-causing bacteria
  • increasing blood flow in oral tissues increasing salivation
  • promoting gingival tissue regeneration fostering osteogenesis in the boney structures of the teeth, mouth and related areas
  • treating systemic diseases associated with oral bacteria and treating other periodontal and oral maladies through the non-invasive application of weak
  • One aspect of the present invention includes a device including an electrical power source and a plurality of electrically conductive surfaces (which may include an electrically conductive polymer and/or fabric) on an external surface of the device.
  • the treatment device may be provided to the animal to be drawn at least partially into its mouth and in contact with an oral secretion or tissue, such as at least one of saliva, lingual tissue, dental tissue, gingival tissue, periodontal tissue, and oral mucosa tissue.
  • the oral secretion and/or tissue provides an electrically conductive path between at least two of the conductive surfaces and electrical current is delivered to the electrically conductive path by at least one of the conductive surfaces.
  • the treatment device may regulate the current that is delivered, such as from about 50 microamps to about 500 microamps, with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred.
  • the device may further include the step of activating the treatment apparatus an on/off switch, which may be a motion- activated switch (such as a reed switch in combination with a magnet) , an accelerometer, or a moisture-activated switch .
  • an on/off switch which may be a motion- activated switch (such as a reed switch in combination with a magnet) , an accelerometer, or a moisture-activated switch .
  • the treatment device may include a timer, which may cease delivery of electrical current or potential to the conductive surfaces, such as by disconnecting the power source from the conductive surfaces, after a predetermined time.
  • the electrical current delivered by the treatment apparatus may be direct current, which may be pulsed direct current. Additionally or alternatively, the treatment apparatus may be capable of delivering alternating current, which may be pulsed, and delivered at a constant or variable frequency.
  • Figure 1 is a perspective view of a first embodiment of a device according to the present invention .
  • Figure 2 is a front elevation view of the embodiment shown in Figure 1.
  • Figure 3 is a right side elevation view of the embodiment of Figure 1.
  • Figure 4 is a top plan view of the embodiment of Figure 1.
  • Figure 5 is a bottom plan view of the embodiment of Figure 1.
  • Figure 6 is a cross-sectional view taken along line 6-6 of Figure 2.
  • Figure 7 is a cross-sectional view taken along line 7-7 of Figure 3.
  • Figure 8 is a cross-sectional view taken along line 8-8 of Figure 4.
  • Figure 9 is a schematic view of an embodiment of an electrical circuit according to the present invention .
  • Figure 10 is a front elevation view of a second embodiment of a device according to the present invention .
  • Figure 11 is a cross-sectional view taken through the center of the embodiment of Figure 10, parallel to the elevation view of Figure 10.
  • testing has examined the effects of direct current stimulation on three different oral bacteria (F. nucleatum, S. oralis, P. gingivalis) in both saline and saliva solutions. This testing varied the current levels, inoculum size of bacteria, solution medium, and treatment time to develop an optimal treatment to reduce these three bacteria species associated with both periodontal and systemic diseases.
  • SEM scanning electron microscopy
  • the electroporation caused by the method according to this invention could play a role in developing new therapies in molecular biology which would take advantage of this cellular permeability and introduce new material into the cells of oral pathogens or oral tissues through mechanisms including, but not limited to genetic material (transfection) such as DNA, RNA, sRNA, siRNA, plasmids, etc. These effects would prove a new tool in targeted gene therapies for oral applications.
  • devices according to the present invention may be used to reduce viable colony forming units (CFU) in various oral bacteria.
  • CFU viable colony forming units
  • the treatment apparatus 100 generally includes a body 110 extending longitudinally between and including a first end 112 and a second end 114 opposite the first end 112.
  • the body 110 is preferably a general hourglass shape. While the hourglass shape could be provided in a variety of fashions, a preferred structure includes the outward appearance of a plurality (e.g., at least three) of circumferential ridges 116 defined by a plurality of stacked toroids. While the term "toroid" is utilized to describe the general outward appearance of portions of the body 110, it is understood that the internal construction of the body 110 may not include corresponding toroidal configurations.
  • the "toroid" language generally describes a ridge 116 having a continuous curved outer surface of a preferred radius R, wherein such radius R extends from a centerpoint C that resides on a circle which extends about a central longitudinal axis A of the body 110.
  • a first circumferential ridge 116a is preferably disposed at or near a longitudinal midpoint of the body 110.
  • This circumferential ridge 116a has a first ridge diameter (118a in Fig. 7), which may be the smallest of any of the ridges 116.
  • a second circumferential ridge 116b is preferably disposed at the second end 114 of the body 110.
  • This circumferential ridge 116b has a second ridge diameter (118b in Fig. 8), which is larger than the first ridge diameter 118a, and it further may be the largest diameter of any of the ridges 116.
  • a third circumferential ridge 116c is preferably disposed at the first end 112 of the body 110.
  • This circumferential ridge 116c has a third ridge diameter (118c in Fig. 7), which is larger than the first ridge diameter 118a, and it may be the same as or smaller than the second ridge diameter 118b.
  • the anchors 120 preferably provide a location at which to, for example, dock a flexible handle 122, such as a rope.
  • the rope 122 may be inserted through the anchor 120, such as through an aperture (124 in Fig. 7) formed at least partially in the anchor 120, and possibly partially into the second circumferential ridge 116b.
  • the rope 122 could then be provided with a slip-stop 126, such as a knot or aglet.
  • the plurality of anchors 120 is preferably equally spaced about a circumference of the body 110 extending about the longitudinal axis A.
  • One or more cavities may extend inwardly from an exterior surface of the body 110.
  • a first cavity 128 extends into the body 110 from the first end 112.
  • the cavity 128 is preferably formed symmetrically about the longitudinal body axis A, extending into the body 110 for a preferred depth, which may be less than half of the longitudinal length of the body 110, which extends between and includes the first end 112 and the second end 114.
  • the cavity 128 extends from an aperture 130 formed in the first end 112 to a closed end 132 disposed within the body 110.
  • the aperture 130 extends about a diameter 134 defined by an annular ridge 136, and the cavity 128 expands outwardly to a second, larger diameter 138 on the inside of the ridge 136.
  • the cavity 128 is defined by a substantially frustoconical wall 140, ending with a terminal diameter 142, which is preferably smaller than both the aperture diameter 134 and the larger diameter 138.
  • a second cavity 144 may also be provided in the body 110.
  • the second cavity 144 may extend into the body 110 from the second end 114, and may be provided as a cylindrical or a stepped reentrant bore.
  • the second cavity 144 extends into the body 110 for a preferred depth, but preferably does not extend so far as to intersect the first cavity 128.
  • a divider 146 which is preferably a solid, non- conductive divider formed of the same nonconductive material as a majority of the body 110.
  • At least two electrodes are provided and electrically accessible on the material forming the outer surface of the device 100.
  • a cathodic electrode element 150 is provided on an external surface of at least one of the ridges 116.
  • an anodic electrode element 160 is provided on an external surface of at least one of the ridges 116.
  • the body 110 is generally formed from a first, electrically insulative material 170 and a second, electrically conductive material 180.
  • the insulative material 170 may be injection molded from a desirable material in a first mold, which may include a removable insert defining wells 172 to receive the conductive material 180 after the insulative material 170 is cured.
  • the conductive material 180 is placed into electrical communication with the electronics module 148 through one or more connection passages 174.
  • the wells 172 preferably have a radial surface area that is larger than the longitudinal cross- sectional area of the connection passage 174.
  • the conductive material 180 is preferably exposed within the second cavity 144 through the connection passage 174.
  • a wire (not shown) or other electrical connection could be used.
  • the conductive material 180 comprises a resilient material (preferably durometer Shore A range of about 25 to about 80, or even up to about 90-95) to encourage chewing of the treatment apparatus 100.
  • a conductive silicone, urethane, fluorosilicone, or other conductive polymer or a conductive fabric e.g.
  • the covering material may be used as, or as a part of, the covering material. Regardless of the covering material used, it is preferred that at least a portion of the material forming the outer surface of the apparatus conducts electricity from the power supply, or regulated amount thereof, to the animal's mouth.
  • the conductive material portions 180 are preferably separated by non- conductive material 170, such as an insulative polymer (e.g. non-conductive silicone) or fabric, preferably having approximately the same durometer Shore A hardness as the conductive material, or a similar tooth feel thereto. Alternatively, in another preferred embodiment, the hardness of the non-conductive material 170 is less than that of the conductive material 180, such as about half. While the conductive material 180 may be disposed in the wells 172, the device 100 is preferably provided with a substantially or completely imperforate radial outer surface.
  • the cathodic electrode 150 may be formed into a variety of configurations, but a preferred configuration includes a cathodic stem portion 152, from which one or more cathodic branches 154 extend.
  • the cathodic stem 152 preferably extends along a majority of the length of the body, generally parallel to the longitudinal axis A.
  • the cathodic branches 154 are preferably formed integrally with the stem 152, but preferably extend annularly from the stem 152, more preferably being disposed on the radially outermost surface of respective ridges 116 of the body 110.
  • an anodic electrode 160 is separated from the cathodic electrode 150 by insulative material 170.
  • a preferred anodic electrode configuration includes an anodic stem portion 162, from which one or more anodic branches 164 extend.
  • the anodic stem 162 preferably extends along a majority of the length of the body, generally parallel to the longitudinal axis A.
  • the anodic stem 162 may be diametrically opposed from the cathodic stem 152.
  • the anodic branches 164 are preferably formed integrally with the anodic stem 162, but preferably extend annularly from the anodic stem 162, more preferably being disposed on the radially outermost surface of respective ridges 116 of the body 110.
  • a plurality of ridges 116 preferably includes a cathodic branch 154 and an anodic branch 164 on each ridge 116.
  • the circuit 200 generally includes a control board 210 and a power supply 230.
  • the control board 210 and power supply 230 may be of any types known to provide an ability to transfer the power of the power supply 230 to the electrodes 150 and 160, which were previously described.
  • Fully contemplated within the purview of the present invention to be included in the circuit 200 are timers, audible (e.g., sounds representative or imitative of a mouse squeak or bird chirp), tactile/haptic (e.g.
  • vibrations provided by a vibratory motor such as a coin or pancake vibration motor
  • visible prompts or feedback or usage, activity and/or power indicators (e.g. beeper, buzzer, light-emitting diodes), motion activation (e.g. using an accelerometer) , moisture activation, pressure activation, electrical current intensity adjustment (e.g., based on sensed impedance between a cathode 150 and an anode 160), and/or an on/off switch 232 to control the possible current delivery by the power supply 230.
  • a vibratory motor such as a coin or pancake vibration motor
  • motion activation e.g. using an accelerometer
  • moisture activation e.g. using an accelerometer
  • pressure activation e.g., pressure activation
  • electrical current intensity adjustment e.g., based on sensed impedance between a cath
  • a programmable microcontroller (or a pre-programmed ASIC) could be used, as previously described, to control the various functions prompts/feedback and could record various treatment parameters and/or treatment history in non-volatile memory to be analyzed in real-time or post- treatment.
  • a programming interface may be provided, such as a wired (e.g., Universal Serial Bus) or a wireless (e.g., Bluetooth®, WiFi (e.g., IEEE 802.11), infrared, etc.) interface to allow programming of the microcontroller, thereby enabling it to control the operation of the device.
  • Parameters that may be desirably programmed may be electrical stimulation intensity (e.g.
  • the power supply 230 may be a simple dry-cell battery, a rechargeable battery, a capacitor, a kinetic energy generator, a piezoelectric generator, a microcontrolled DC power supply, or other power supply (such as a microcontrolled AC power supply) . Regardless of the power supply 230 used, it is most preferable to control the amount of electrical current delivered by the treatment device to provide a relatively constant current power source to provide up to about 500 microamps of direct or alternating current. While 50 microamps to about 500 microamps may be a desired range, about 50 microamps to about 250 microamps is preferred, and about 100 microamps is still further preferred.
  • Such control may be provided by a microcontroller or discrete monitoring circuitry (such as through current and/or impedance sensing) , or optimal dry-cell design if expected impedances are generally known. It is further contemplated by the present invention that the treatment apparatus 100 is preferably used by non-human animals, such as felines, bovines, ovines, canines, equines, porcines, etc. Power supplies and other circuit components may be found in published U.S. Patent Application Serial Number 13/839,513, which is incorporated herein by reference in its entirety.
  • a circuit will be completed by an animal's mouth when the device 100 is masticated.
  • This is schematically represented in Figure 9 by impedances Ro, provided by the animal's mouth (e.g. saliva and/or oral tissues), extending between two or more electrodes.
  • the circuit 200 contained within the electronics module 148 may be coupled to the conductive material 180 forming the electrodes 150,160 by exposed electrical conductors supported by the module 148 which are placed in frictional contact with the conductive material 180 when the module 148 is inserted into and supported within the second cavity 144.
  • electrical conductors that interface between the power supply 230 and the electrodes 150,160 extend from the power supply 230 in the same direction.
  • a first electrical conductor that couples the cathodic electrode 150 to the positive pole of the power supply 230 preferably extends from the positive pole in a first longitudinal or radial direction.
  • a second electrical conductor that couples the anodic electrode 160 to the negative pole of the power supply 230 preferably extends from the negative pole in the same longitudinal or radial direction as the first electrical conductor.
  • the coupling of the electrodes 150, 160 to the power supply 230 is not required to be a direct coupling, but rather may be indirect coupling through a variety of other electrical passive or active electrical components, such as one or more voltage regulators, operational amplifiers, transistors, microcontrollers, voltage converters /inverters , etc.
  • the circuit 200 be able to supply a stimulation (pulsed or steady) current of about 50 microamps to about 500 microamps to a load (Ro) of up to about 70 kilo-ohms. More preferably, to such load, a stimulation current of about 50-250 microamps, and still more preferably, a current of about 100 microamps has been shown to be effective.
  • Figures 10 and 11 depict features of a second embodiment 200 of a device according to the present invention, where similar reference numerals refer to substantially similar or identical structure as described with respect to the first embodiment 100.
  • one or more cavities may extend inwardly from an exterior surface of the body 210.
  • a first cavity 228 extends into the body 110 from the first end 212.
  • the cavity 228 is preferably formed symmetrically about the longitudinal body axis A, extending into the body 210 for a preferred depth, which may be less than half of the longitudinal length of the body 210, which extends between and includes the first end 212 and the second end 214.
  • the cavity 228 extends from an aperture 230 formed in the first end 212 to a closed end 232 disposed within the body 210.
  • the aperture 230 extends about a diameter 234 defined by an annular ridge 236, and the cavity 228 expands outwardly to a second, larger diameter 238 on the inside of the ridge 236. Extending further inward, the cavity 228 is defined by a substantially frustoconical wall 240, which may be ribbed or textured, ending with a terminal diameter 242, which is preferably smaller than both the aperture diameter 234 and the larger diameter 238.
  • a second cavity 244 may also be provided in the body 210. The second cavity 244 may extend into the body 210 from the second end 214, and may be provided as a cylindrical or a stepped reentrant bore.
  • the cavity 244 may include a retaining lip 245 adapted to maintain the electronics module 248 generally securely within the cavity 244.
  • the second cavity 244 extends into the body 210 for a preferred depth, which may be greater than half of the length of the body 210 along the axis A, but preferably does not extend so far as to intersect the first cavity 228. If the body 210 is provided with a first cavity 228 and a second cavity 244 as described, they are preferably separated by a divider 246, which is preferably a solid, non-conductive divider formed of the same nonconductive material as a majority of the body 210.
  • this embodiment 200 includes at least two electrodes, one cathode 250 and one anode 260, provided and electrically accessible on the material forming the outer surface of the device 200.
  • the stem portions 252, (262 not shown) of this embodiment 200 are serpentine, rather than being substantially linear like the stem portions 152,162 on the first embodiment 100.
  • this embodiment 200 includes one or more ruts 290 adapted to receive an edible substance (e.g. canned dog food or nutrient gel) or a dentifrice.
  • the ruts 290 preferably extend radially about the body 210 for a predetermined length or about a predetermined angle (e.g. 30-60 degrees) about the axis A.
  • a method according to the present invention may be used for promoting oral hygiene in non-human animals, such as felines, bovines, ovines, canines, porcines, and/or equines .
  • the method comprises the steps of providing a treatment apparatus comprising a power source and a plurality of electrodes electrically coupled to the power source.
  • the power source may be an internal direct current power source, or other power source as described above.
  • the plurality of electrodes includes at least one, but preferably a plurality of cathodic electrodes and at least one, but preferably a plurality of anodic electrodes.
  • the electrodes may be positioned in a spaced arrangement about, and preferably conductive through, the exterior of the treatment apparatus by a conductive material.
  • the electrodes may be arranged in an alternating cathodic/anodic fashion about the device.
  • the method further comprises the step of providing such device to a non-human animal, thereby allowing delivery of electrical current from the power source, through the electrodes and to at least one of the animal's oral secretions (e.g., saliva) and oral tissue (e.g., lingual tissue, dental tissue, gingival tissue, periodontal tissue, and oral mucosa tissue) .
  • oral secretions e.g., saliva
  • oral tissue e.g., lingual tissue, dental tissue, gingival tissue, periodontal tissue, and oral mucosa tissue
  • Systems and methods according to the present invention may be used to reduce oral bacteria and/or biofilm, as well as to treat systemic diseases that may be associated with oral bacteria, in non-human animals, such as dogs, cats, sheep, horses, cows, pigs, etc.
  • periodontal disease is one of the most common health problems affecting dogs (> 75%) .
  • the prevalence of periodontal disease has been found to increase age but decrease with body weight.
  • Various systemic diseases have been suggested as a strong co- factor for periodontal disease in animals, just as in humans . It has been suggested that periodontal disease could have a causal relationship with systemic diseases in both humans and animals.
  • periodontitis is a recurrent and persistent disease and exposes the host to negative systemic effects over an extended period of time, e.g. several years.
  • periodontal disease has been linked with gram- negative anaerobic bacteria upon accumulation within the gingival sulcus causing inflammation and the formation of periodontal pockets .
  • the inflammatory response to periodontal pathogens promotes the formation and release of endotoxins and inflammatory cytokines that can decrease functions of vital organs over time.
  • Periodontal diseases may be associated with periodontal disease in dogs, including chronic bronchitis, pulmonary fibrosis, endocarditis, interstitial nephritis, glomerulonephritis, and hepatitis.
  • Periodontal organisms present in dogs with periodontitis have been isolated and identified previously. For instance, the following periodontal pathogens have been found to be associated with periodontal disease in dogs: P. gingivalis (64% of periodontitis-positive dogs) , C. rectus, A. actinomycetemcomitans, P. intermedia, T. forsythensis, F. nucleatum (4% of periodontitis-positive dogs), E. corrodens, P.
  • denticanis, P. gulae, P. salivosa may include a predetermined time, such as 20 minutes, of oral secretions and/or tissue (i.e., saliva, lingual tissue, dental tissue, gingival tissue, periodontal tissue, and/or oral mucosa tissue) exposure to an electrical current (alternating or direct current, constant or pulsed) level of between about 50 microamps ( ⁇ ) and about 500 microamps ( ⁇ ) , with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred.
  • Devices according to the present invention have been shown to be effective at reducing the count of bacterial species in this current range.
  • periodontal disease in cats is associated with local inflammation and is purported to influence and induce systemic responses and organ function in distal sites.
  • One of the common oral pathogens found in the oral cavity of cats is P. gingivalis .
  • Recommended treatments using systems and/or methods according to the present invention to treat and/or prevent periodontal disease in cats by reducing or controlling such types of bacteria may include a predetermined time, such as 20 minutes, of oral tissue exposure to an electrical current (alternating or direct current, constant or pulsed) level of between about 50 microamps ( ⁇ ) and about 500 microamps ( ⁇ ) , with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred.
  • Devices according to the present invention have been shown to be effective at reducing the count of such bacterial species in this current range.
  • Periodontitis may also be found in sheep and cattle, also referred to as "broken mouth", and is associated with severe degradation of periodontal collagen, loss of alveolar bone, appearance of periodontal pockets and premature tooth loss. Although morphological and histological differences exist between the periodontium of sheep, cattle, and humans, the histopathological appearance is similar in periodontal disease, including the role that P. gingivalis plays in the progression of the disease.
  • Recommended treatments using systems and/or methods according to the present invention to treat and/or prevent periodontal disease in sheep and/or cattle by reducing or controlling such types of bacteria may include a predetermined time, such as 20 minutes, of oral tissue exposure to an electrical current (alternating or direct current, constant or pulsed) level of between about 50 microamps ( ⁇ ) and about 500 microamps ( ⁇ ) , with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred.
  • Devices according to the present invention have been shown to be effective at reducing the count of such bacterial species in this current range.
  • Cardiovascular-related conditions may also exist in non-human animals. For instance, there has in dogs been revealed an association between periodontal disease severity and risk of cardiovascular-related conditions, such as endocarditis and cardiomyopathy. Endocarditis is a result of infection and inflammation of the heart endothelium, or tissue lining the inner surface of the heart valves and can be caused by various microorganisms. Cardiomyopathy is characterized by an enlarged heart that does not function properly. Both diseases carry a poor prognosis based on the severity of the case. For dogs, it has been found that the risk of endocarditis was 6-fold higher in dogs with stage 3 periodontal disease than it was for healthy dogs and for cardiomyopathy it was about 4-fold.
  • Cardiac disease progression may be affected by the presence and/or prevalence of certain oral bacteria, including S. oralis, F. nucleatum, and P. gingivalis .
  • Recommended treatments using systems and/or methods according to the present invention to treat and/or prevent cardiac disease by reducing or controlling such types of bacteria may include a predetermined time, such as 20 minutes, of oral tissue exposure to an electrical current (alternating or direct current, constant or pulsed) level of between about 50 microamps ( ⁇ ) and about 500 microamps ( ⁇ ) , with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred.
  • Devices according to the present invention have been shown to be effective at reducing bacterial burden of all three species in this current range.
  • CKD chronic kidney disease
  • Both F. nucleatum and P. gingivalis are common oral pathogens presented in dogs, and may be linked to kidney disease. Accordingly, reduction of such pathogens may be used as a treatment or prevention thereof.
  • Recommended treatments using systems and/or methods according to the present invention to treat and/or prevent kidney disease by reducing or controlling such types of bacteria may include a predetermined time, such as 20 minutes, of oral tissue exposure to an electrical current (alternating or direct current, constant or pulsed) level of between about 50 microamps ( ⁇ ) and about 500 microamps ( ⁇ ) , with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred.
  • Devices according to the present invention have been shown to be effective at reducing the count of such bacterial species in this current range.
  • Non-human animal diabetes may also be treated and/or prevented using systems and methods according to the present invention.
  • diabetes mellitus and periodontal disease, and such a relationship has been suspected in veterinary medicine.
  • blood glucose concentrations are increased in relation to attachment loss and periodontal disease state in dogs. Additionally, these levels decreased following periodontal disease treatment.
  • the S. oralis bacterium has been associated with severe periodontitis and diabetes.
  • Recommended treatments using systems and/or methods according to the present invention to treat and/or diabetes by reducing or controlling such types of bacteria may include a predetermined time, such as 20 minutes, of oral tissue exposure to an electrical current (alternating or direct current, constant or pulsed) level of between about 50 microamps ( ⁇ ) and about 500 microamps ( ⁇ ) , with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred.
  • Devices according to the present invention have been shown to be effective at reducing the count of such bacterial species in this current range. Such a reduction may help combat high levels of blood glucose.
  • systems and methods according to the present invention may be used to affect (preferably reduce and/or eliminate) the number of oral bacteria transferred between animals of different species, such as between a pet and its owner.
  • oral bacteria including periodontal pathogens
  • P. gulae was detected in 7 1 . 2 % of dogs in the study and 1 6% in the owners.
  • P. gulae bacterium a member of the Porphyromonas genus found in the oral cavity of dogs, has been shown to share 60 % homology with P. glnglvalls . This suggests that P. gulae would respond similarly to treatment with the device as does P. gingivalis.
  • Recommended treatments using systems and/or methods according to the present invention to remedy and/or prevent the transfer of oral bacteria between animals of different species by reducing or controlling such types of bacteria may include a predetermined time, such as 20 minutes, of oral tissue exposure to an electrical current (alternating or direct current, constant or pulsed) level of between about 50 microamps ( ⁇ ) and about 500 microamps ( ⁇ ) , with about 50 microamps to about 250 microamps being preferred, and about 100 microamps being still further preferred. Either or both animals (e.g. a dog and/or its owner) may be so treated.
  • Devices according to the present invention have been shown to be effective at reducing the count of such bacterial species in this current range. Such treatment should reduce levels of P. gulae and diminish the possibility of pathogen transmission to the animal's owner.
  • the treatment times may be a constant treatment time (e.g. 20 consecutive minutes) or treatments may be prescribed and/or delivered for a predetermined period of time (e.g. 1-60 minutes) within a treatment window (e.g. 24 hours, one week, one month, etc.) in shorter incremental treatments, such as two minutes, five times a day (to achieve 10 minutes of stimulation within a treatment window of 24 hours) .
  • a predetermined period of time e.g. 1-60 minutes
  • a treatment window e.g. 24 hours, one week, one month, etc.
  • incremental treatments such as two minutes, five times a day (to achieve 10 minutes of stimulation within a treatment window of 24 hours) .
  • embodiments according to the present invention are able to achieve multiple prophylactic, therapeutic, and regenerative effects in non-human animals whose combination was not previously known or available in the art. Namely, these effects are: promotion of oral osteogenesis, destruction or disabling of oral microbes, gingival tissue regeneration, reduction and prevention of the formation of oral biofilms, caries prevention, increased oral vasodilation and oral blood flow, treatment of common oral conditions such as gingivitis and periodontitis, treatment of systemic diseases and conditions correlated with oral pathogens, and generally improved oral hygiene.
  • the electrodes may be fashioned out of any electrically-conductive material, including but not limited to metals such as silver, stainless steel, copper, gold, platinum, palladium, aluminum, an alloy thereof, electrically- conductive nanotubes, carbonized rubber, electrically- conductive silicone, or electrically-conductive polymers.
  • the electrodes may be composed of the same or of differing materials.
  • the adjustable power supply is capable of delivering a stable, direct current in the approximate range of 1 to 500 microamperes.
  • the preferred current setting for most treatments is in the approximate range of 50 to 250 microamperes, with about 100 microamps being still further preferred.
  • At least one embodiment herein addresses a desired need in the non- human animal oral hygiene and dental fields to treat common oral diseases and conditions in a more effective, less invasive, and less expensive manner.
  • These embodiments promote general oral hygiene, reduce oral biofilm, treat periodontal diseases such as gingivitis and periodontitis, kill oral microbes including bacteria and thus preventing cavities and tooth decay, increase vasodilation and blood flow in oral tissues, promote gingival tissue regeneration, foster osteogenesis in the boney structures of the teeth, mouth, and related areas, treat systemic diseases related to oral pathogens, and treat other periodontal and oral maladies through the non-invasive application of weak direct current electricity to the surfaces in the oral cavity.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Electrotherapy Devices (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne des systèmes et des méthodes de traitement concomitant d'affections et de défauts buccaux multiples tout en favorisant l'hygiène buccale générale chez les animaux non humains, par l'utilisation d'électricité. Des électrodes sont utilisées en vue d'administrer un courant électrique aux tissus gingivaux de la bouche de sorte à obtenir une série d'avantages thérapeutiques, prophylactiques et régénératifs. Ces avantages incluent l'élimination de microbes buccaux, l'accroissement de la vasodilatation buccale, la réduction du biofilm buccal, l'amélioration de la circulation sanguine buccale, l'inversion de la résorption osseuse buccale, la promotion de l'ostéogenèse buccale, le traitement de la récession gingivale, et la stimulation de la régénération gingivale. D'autres avantages incluent le traitement de la gingivite, de la parodontite et de la mauvaise haleine, et d'autres maladies systémiques en corrélation avec des agents pathogènes buccaux.
PCT/US2015/010477 2014-01-07 2015-01-07 Traitement d'affections buccales au moyen d'un courant électrique WO2015105873A1 (fr)

Priority Applications (4)

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CA2936087A CA2936087C (fr) 2014-01-07 2015-01-07 Traitement d'affections buccales au moyen d'un courant electrique
AU2015204825A AU2015204825A1 (en) 2014-01-07 2015-01-07 Treatment of oral maladies using electrical current
EP15735071.1A EP3092031A4 (fr) 2014-01-07 2015-01-07 Traitement d'affections buccales au moyen d'un courant électrique
AU2019250172A AU2019250172B2 (en) 2014-01-07 2019-10-16 Treatment of oral maladies using electrical current

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US201461924381P 2014-01-07 2014-01-07
US61/924,381 2014-01-07

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EP3092031A1 (fr) 2016-11-16
US20170296809A1 (en) 2017-10-19
US20190167979A1 (en) 2019-06-06
US20220257930A1 (en) 2022-08-18
CA2936087A1 (fr) 2015-07-16
EP3092031A4 (fr) 2017-09-27
US20150190631A1 (en) 2015-07-09
AU2019250172A1 (en) 2019-10-31
US10201698B2 (en) 2019-02-12
AU2015204825A1 (en) 2016-07-28
CA2936087C (fr) 2023-02-28
AU2019250172B2 (en) 2021-12-02
US11324946B2 (en) 2022-05-10

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